Post-anesthetic recovery delay and sedation-related complications in patients undergoing colonoscopy with total intravenous anesthesia using propofol-based protocols in a community hospital setting. Lidocaine Midazolam Propofol Anesthesia, Intravenous Conscious Sedation Anesthesia Recovery Period Colonoscopy Randomized Controlled Trial
Conditions
Interventions
Participants will receive intravenous lidocaine (1.5 mg/kg) diluted in 0.9% normal saline to 10 mL, administered slowly as a single bolus during induction, following propofol (0.5 mg/kg) and fentanyl
Active Comparator Drug,Active Comparator Drug
Lidocaine,Midazolam
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Scheduled to undergo elective diagnostic or screening colonoscopy under intravenous anesthesia 2. Classified under the American Society of Anesthesiologists physical status classification I, II, or III
Exclusion criteria
Exclusion criteria: 1. Patients with significant pre-existing cardiovascular conditions including New York Heart Association (NYHA) Class III or IV heart failure, resting heart rate less than 50 beats per minute, uncontrolled cardiac arrhythmias, documented acute coronary syndrome or unstable angina within the preceding 3 months, severe valvular heart disease, or uncorrected hypotension 2. Severe hepatic impairment, defined as Child-Pugh class B or C, or significantly elevated liver enzymes (Aspartate Aminotransferase [AST] or Alanine Aminotransferase [ALT] greater than 3 times the upper limit of normal) 3. Severe renal dysfunction, defined as estimated Glomerular Filtration Rate (eGFR) less than 15 mL/min/1.73 m2 4. Severe Chronic Obstructive Pulmonary Disease (COPD) 5. Clinically diagnosed Obstructive Sleep Apnea (OSA) 6. Severe obesity, defined as Body Mass Index (BMI) greater than 35 kg/m2 7. Documented significant neurological or psychiatric disorders that could affect cooperation or assessment 8. Recent use (within the preceding 24 hours) of sedative or psychoactive substances (excluding chronic stable use of prescribed psychotropic medications deemed compatible by the attending anesthesiologist) 9. Pregnancy 10. Requirement for emergency colonoscopy 11. Known history of allergy or hypersensitivity reaction to Propofol, Fentanyl, Midazolam, Lidocaine, or any of their components 12. Patients who declined to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery Time After the cessation of Propofol administration at the end of the colonoscopy procedure. The duration, measured in minutes, from the cessation of Propofol administration at the end of the colonoscopy procedure until the patient achieved a Modified Aldrete Score (MAS) of 9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Propofol Consumption Throughout the entire colonoscopy procedure, from induction of anesthesia until the end of the procedure. The cumulative dose of Propofol administered intravenously throughout the procedure, recorded in milligrams (mg).,Post-Anesthesia Care Unit Length of Stay (PACU LOS) Throughout the PACU stay, from admission to PACU until actual discharge from PACU. The total time, measured in minutes, from the patient's arrival in the PACU until the patient's discharge from the PACU.,Incidence of sedation-related adverse events and resuscitative interventions Throughout the entire colonoscopy procedure, from induction of anesthesia until the end of the procedure. Occurrence of hypotension, bradycardia, apnea, oxygen desaturation, and use of resuscitative interventions. Recorded as Yes or No for each event.,Incidence of Post-anesthetic Confusion Throughout the PACU stay, from admission to PACU until actual discharge from PACU. Occurrence of post-anesthetic confusion assessed using the Confusion Assessment Method (CAM) in the PACU when the patient is sufficiently alert to undergo assessment. Recorded as Yes or No.,Incidence of Postoperative Nausea and Vomiting (PONV) Throughout the PACU stay, from admission to PACU until actual discharge from PACU. Occurrence of nausea and vomiting assessed by direct questioning and observation in the PACU prior to discharge. Recorded as Yes or No.,Endoscopist satisfaction Immediately following the procedure. Endoscopist's 5-level Likert questionnaire on patient cooperation, sedation, procedure smoothness, complication impact, overall anesthesia satisfaction. | — |
Countries
Thailand
Contacts
Public ContactPiyaporn Onlamai
Kaeng Khro Hospital, Ministry of Public Health
Outcome results
None listed